A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer.
研究概览
简要总结
The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.
详细描述
This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease
- •Any prior chemotherapy is allowed in this protocol.
- •No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
- •No prior abdominal or pelvic radiotherapy.
- •Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes greater than or equal to 3,000 G/L
- •Platelets: greater than or equal to 100,000/mm3
- •Hemoglobin:greater than or equal to 10g/L
- •Total bilirubin: within normal institutional limits
- •AST/ALT: less than or equal to 1.5 times the upper limit
- •Creatinine within normal upper limits
- •Informed consent
- •Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.
排除标准
- •Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- •With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
- •History of allergic reactions attributed to similar chemical or biologic complex to S-1
- •Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- •History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- •History of prior radiation to the abdomen
- •Pregnant or lactating females
研究组 & 干预措施
S-1,peroral BID,capsule
干预措施: S-1 (Drug)
结局指标
主要结局
To define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer.
时间窗: up to 9 weeks
Dose limited toxicities defined as below: leucopenia ≥4 neutropenia ≥ 4, anemia ≥ 3, thrombocytopenia ≥ 3, alanine aminotransferase/aspartate aminotransferase (AST) ≥ 3, alkaline phosphatase (ALT) ≥ 3, total bilirubin ≥ 3,blood urea nitrogen (BUN)/Cr ≥ 2,non-granular cell decreased fever ≥ 2, nausea/vomiting ≥ 2, fatigue ≥ 3, weight loss ≥ 3, diarrhea ≥ 3, abdominal pain ≥ 3, dysphagia ≥ 3, hand-foot syndrome ≥ 2, neurotoxicity ≥ 2.
次要结局
- To define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapy(up to 9 weeks)
研究者
Wang Xin
Dr.
Chinese Academy of Medical Sciences